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FDA 510(k)

EYETECT TREMOR MONITOR UNIT (TMU)

K-Number: K003644 · 2001-02-01

ApplicantEyetect, LLC
Decision Date2001-02-01
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EYETECT TREMOR MONITOR UNIT (TMU) is the device name listed in this FDA 510(k) record. The listed applicant is Eyetect, LLC. It received FDA 510(k) clearance on 2001-02-01 under 510(k) number K003644. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYETECT TREMOR MONITOR UNIT (TMU)?

EYETECT TREMOR MONITOR UNIT (TMU) is a medical device that received FDA 510(k) clearance on 2001-02-01. The listed applicant is Eyetect, LLC. The 510(k) number is K003644.

When did EYETECT TREMOR MONITOR UNIT (TMU) receive FDA 510(k) clearance?

EYETECT TREMOR MONITOR UNIT (TMU) received FDA 510(k) clearance on 2001-02-01, under 510(k) number K003644.

Who is the listed applicant for EYETECT TREMOR MONITOR UNIT (TMU)?

The FDA 510(k) record lists Eyetect, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYETECT TREMOR MONITOR UNIT (TMU)?

The FDA product code for EYETECT TREMOR MONITOR UNIT (TMU) is GWN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GWN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260566SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc.K243709NeuroEars-Anna™Neuroears, Inc.K242198ICS Dizcovery (1091)Natus Medical Denmark ApsK242726Synapsys VHITInventis S.R.L.K223047NeuroSwift ProNeurobit Technologies Co., Ltd.K203082Insight Infrared Video GogglesVestibular First

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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